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Office of the Press Secretary

For Immediate Release April 1, 1993



Short Title and References in the Act

Section 1 assigns the draft bill the short title "Comprehensive Child Immunization Act of 1993". It also states that all amendments in this Act apply to the Public Health Service Act unless otherwise specifically provided.

Purpose of the Act

Section 2 states that the purpose of the draft bill is to ensure that all children in the United States are protected against vaccine preventable infectious diseases at the earliest appropriate age; to establish a program to purchase vaccines and to distribute them to all willing health care providers; to establish a tracking program to monitor which children need to be immunized and the results of immunizing children; and to extend the National Childhood Vaccine Injury Compensation Program.

Findings of Congress

Section 3 sets forth the findings of Congress regarding the current status of childhood immunization efforts and actions needed to ensure the full immunization of all children in the United States at the earliest possible age.

Federal Purchase and Tracking of Childhood Vaccines

Subsection (a) of section 4 establishes a new Subtitle 3 in Title XXI of the Public Health Service Act.

New section 2141 addresses Federal purchase of recommended childhood vaccines.

Subsection (a) of section 2141 directs the Secretary to promulgate a list of vaccines that provide immunization against naturally occurring infectious diseases and are recommended for universal use in children, along with recommendations regarding appropriate dosage and age for administration. The Secretary is required to promulgate the first list by October 1, 1994, and to promulgate an updated list as warranted by medical developments.

Subsection (b) of section 2141 requires the Secretary to consult with Federal agencies involved in research regarding, or the regulation, procurement, or distribution of recommended childhood vaccines regarding, the quantities of vaccine to purchase. She may establish a Vaccine Requirements Panel to advise her or use whatever other method of conducting consultations she finds appropriate.

Paragraph (1) of subsection (c) of section 2141 directs the Secretary to purchase recommended childhood vaccines in

quantities sufficient to meet anticipated needs for routine and catch-up immunizations of children and foreseeable outbreak control activities, and to maintain a reserve supply sufficient for a six-month period. The Secretary is directed to negotiate a reasonable price that takes fairly into account the various costs described in paragraph (3).

Paragraph (2) of subsection (c) authorizes the Secretary to consult with representatives of State governments, experts in vaccine delivery, health care providers, and other experts prior to commencing negotiations for the purchase of vaccine.

Paragraph (3) of subsection (c) requires vaccine manufacturers participating in a procurement for recommended childhood vaccine instituted by the Secretary to furnish detailed cost or pricing data to the Secretary. The required data includes data related to research and development costs, production costs, costs associated with the distribution of vaccine to States and health care providers, marketing costs, profit levels sufficient to encourage future investment in research and development, the cost of maintaining adequate capacity for outbreak control, and any other data the Secretary determines is relevant.

Paragraph (4) of subsection (c) addresses the confidentiality accorded financial information submitted by manufacturers under paragraph (3). Subparagraph (A) directs that the information be treated as trade secret or confidential information for purposes of the Freedom of Information Act and provides for criminal sanction provisions. Subparagraph (B) states that subparagraph (A) does not authorize the withholding of the financial information from a duly authorized subcommittee or committee of the Congress. (A request from the Congress for this information would be handled in accordance with current practices governing trade secret information.) Written notice is required to be furnished to the manufacturer whenever the Secretary provides information to the Congress. Subparagraph (C) directs the Secretary to establish written procedures to ensure the confidentiality of the information.

Paragraph (5) of subsection (c) prohibits any manufacturer with which the Secretary contracts for the purchase of recommended childhood vaccine from imposing any shipping or handling charges on States or health care providers receiving the federally purchased vaccine. (Costs related to the distribution of vaccine are covered by the price negotiated by the Secretary.)

Paragraph (6) authorizes the Secretary to enter into contracts with multiple manufacturers of the same recommended childhood vaccine to ensure a reliable and adequate supply of vaccines and to stimulate competition.

Paragraph (7) requires a manufacturer that sells recommended childhood vaccine to the Secretary to provide data on the shipment of doses by lot number, and any other information the Secretary may require.

New section 2142 addresses the distribution of recommended childhood vaccine.

Subsection (a) of section 2142 directs the Secretary to provide (either directly or through States) for the free distribution of vaccine to health care providers who serve children and are located in a State that participates in the State registry grant program under section 2143(b). In States not participating in the State registry grant program, free vaccine will be distributed to Federal health care providers, community health centers, migrant health centers, health centers serving residents of public housing or the homeless, other federally qualified health centers, and health care providers serving Indians under section 503 of the Indian Health Care Improvement Act or pursuant to a contract under section 102 of the Indian Self-Determination Act.

Subsection (b) imposes duties on health care providers receiving free vaccine. Providers may not charge patients for the cost of the vaccine, but may impose a fee for its administration unless such a fee would result in the denial of vaccine to someone unable to pay. Providers are required to report to the State tracking registry (or to the Secretary if there is no State registry) information regarding each vaccine administered. Providers are also required to provide periodic estimates of their future needs for vaccine.

New section 2143 provides for a collaborative Federal and State effort to track the immunization status of the Nation's children.

Subsection (a) requires the Secretary to establish a National Tracking System designed to monitor the various aspects of immunization efforts under subtitle 3. In addition, the Secretary is authorized, in the case of inadequately immunized children in a State not participating in the State registry grant program, to notify their parents or guardians of the need to protect their children with specific vaccine.

Paragraph (1) of subsection (b) authorizes the Secretary to make grants to States to establish and operate State immunization tracking registries and specifies the minimum information to be recorded in the registry for each child within the State.

Paragraph (2) imposes grant conditions, including timely entry of data on covered children; exchanging information with health care providers, the Secretary, and other States; adherence to Federal tracking models and systems specifications regarding registry design; and monitoring provider compliance with reporting and other requirements.

Paragraph (3) sets out requirements applicable to applications for State registry grants.

Paragraph (4) requires a State to furnish satisfactory assurances that its registry will be fully operational by October 1, 1996, and will adhere to the tracking models and systems specifications prescribed by the Secretary. It also requires assurances, as appropriate, that the State is making satisfactory progress toward meeting those requirements.

Paragraph (5) specifies allowable uses of grant funds.

Paragraph (6) requires each State receiving a registry grant to submit periodic reports to the Secretary.

Subsection (c) addresses the use and disclosure of personal information collected under subtitle 3.

Paragraph (1) of subsection (c) states the general rule that no personally identifiable information collected by the National Tracking System or a State tracking registry may be used or disclosed except as permitted by subsection (c).

Paragraph (2) lists the allowable purposes for which the information may be used or disclosed, including tracking children's immunization status, activities related to maintaining safe and effective supplies of vaccine, processing insurance claims, administering the National Vaccine Injury Compensation Program, health research, and program oversight.

Paragraph (3) provides for the use and disclosure of information with the written authorization of the individual to whom it refers (or to the parent or guardian of such individual), and requires that, upon their request, individuals be provided information about themselves.

Paragraph (4) authorizes the Secretary to issue regulations governing the use, maintenance, and disclosure of the covered information.

Paragraph (5) provides a criminal penalty for violation of subsection (c).

Paragraph (1) of subsection (d) authorizes the Secretary and States to utilize social security numbers to identify children in their tracking systems, and to require a parent or guardian to furnish a number (whenever a number has been assigned by the Social Security Administration) as a condition of receiving free vaccine. Paragraph (2) confers basic authority on the Secretary and the States to redisclose social security numbers consistent with the requirements of registry operations.

Subsection (e) of section 2143 requires the Secretary to report to the Congress not later than January 1, 1996, and biennially thereafter, on the operation of the national tracking system and the State registries.

New section 2144 defines the terms "recommended childhood vaccine" and "health center."

New section 2145 provides appropriations for the vaccine purchase program under the new subtitle, and authorizes appropriations for tracking and start-up activities.

Subsection (a) provides for the financing mechanism to carry out the vaccine purchase program described above. The funds would come from a separate account in the Treasury. The sources of revenue that will be deposited into the account in the Treasury will be identified in legislation for broad-based reform of the national health care system when it is submitted to the Congress by the President in May. This funding will be available beginning with fiscal year 1995 and for each of the following years in which the vaccine purchase program remains in effect. (The sunset provision applicable to the vaccine purchase program is described below.)

For the purpose of making State registry grants, operating the National Tracking System, and carrying out other activities, subsection (b) of section 2145 authorizes the appropriation of $152 million for fiscal year 1995, $125 million for fiscal year 1996, and $35 million for each of the fiscal years 1997, 1998, and 1999.

For the purpose of funding start-up costs associated with activities to implement the Comprehensive Child Immunization Act of 1993, subsection (c) of section 2145 authorizes the appropriation of such sums as may be necessary for fiscal years 1993 and 1994 (which are in addition to other amounts available to carry out current law).

Subsection (b) of section 4 requires State Medicaid programs, as part of their required Early and Periodic Screening, Diagnosis, and Testing (EPSDT) program for children, to cover all recommended childhood vaccines, as defined in section 2144 of the Public Health Service Act. This section also requires that Medicaid payments to providers include amounts, as appropriate, to reimburse for administration of these immunizations. These amendments would be effective for quarters beginning after September 30, 1994.

Subsection (c) of section 4 provides that subsections (b) and (c) of section 2141, providing the broad authority for the Secretary to purchase recommended childhood vaccines, will cease to be in effect when those subsections are superseded or terminated by a national health care reform law.

National Vaccine Injury Compensation Program Amendments

Subsection (a) of section 5 addresses use of the Vaccine Injury Compensation Trust Fund. It amends the Internal Revenue Code to allow payments from the Trust Fund for compensable injuries from vaccines administered on or after October 1, 1992. Under current law, payments are no longer authorized if the vaccine was administered after September 30, 1992. This subsection also amends the Omnibus Budget Reconciliation Act of 1989 to authorize appropriations from the Trust Fund for years after fiscal year 1992 (the latest year specified in the current law authorization) for administrative costs of the Departments of Justice and Health and Human Services, and for the United States Court of Federal Claims, to carry out the National Vaccine Injury Compensation Program. The annual authorization for each of those agencies is increased from $2.5 to $3 million to reflect the responsibilities attendant on adding additional vaccines to the program.

Subsection (b) of section 5 contains amendments related to the permanent extension and reinstatement of the vaccine excise tax. Subsection (b) repeals the Internal Revenue Code provision that authorizes the Secretary of the Treasury to terminate the vaccine excise tax. This provision also provides for reinstatement of the excise tax (which was terminated at the end of 1992) beginning on April 2, 1993.

Subsection (c) of section 5 relates to amendment of the Vaccine Injury Table. Subsection (c) adds a new section 2114(f) to the Public Health Service Act. The new subsection states that any vaccine recommended for universal administration to children by the Secretary would be included on the Vaccine Injury Table established by section 2114(a). This occurs by operation of law and no further administrative or legislative action would be needed. Although no conditions would be provided initially on the Table for the new vaccines, petitioners would be able to prevail on a petition for compensation by showing, by a preponderance of the evidence, that the vaccine in fact caused the alleged injury. The Secretary would have authority with respect to any vaccine so added to modify the Table, as may be done under current law with respect to vaccines on the original Table, but only in accordance with the notice, hearing, and comment procedures, and other authorities and limitations contained in section 2114(c).

Subsection (d) of section 5 allows the chief special master to suspend proceedings on petitions for up to 30 months, rather than the 540 days (18 months) in current law. This authority applies to the retrospective claims and is in addition to suspensions permitted under other provisions of the law.

Subsection (e) makes amendments intended to simplify vaccine information materials. Subsection (e) amends section 2126 of the Public Health Service Act, which requires the development and distribution of vaccine information materials. The amendments are designed to expedite the process of formulating and revising the materials, and to allow the simplification of their content. To achieve these objectives--

Additionally, the introductory language of section 2126(c) (describing the content of the vaccine information materials) is amended to require that the materials provided be based on available data and information.

Finally, paragraph (3) amends section 2126(d) at each appropriate place to require the furnishing of materials to any individual (not just the representative of a child) receiving a listed vaccine. Under paragraph (4), the health care provider would supplement the written materials with visual presentations or oral explanations in appropriate cases.

Funding for Child Immunization Program

Section 6(a) directs the establishment and maintenance of a Comprehensive Child Immunization Account in the United States Treasury. The sources of revenue that will be deposited into the Comprehensive Child Immunization Account will be identified in legislation for broad-based reform of the national health care system when it is submitted to the Congress by the President in May. (The amounts in the Account will be available to the Secretary of Health and Human Services to carry out the timelimited program under which recommended childhood vaccines are purchased and distributed.)

The effect of this proposal is:

                           Fiscal Years
                     (in millions of dollars)

          1994      1995      1996      1997      1998      1994-1998

Outlays             1,074     1,164     1,268     1,194        4,700
Revenues            1,074     1,164     1,268     1,194        4,700

     The program of universal vaccine purchase and distribution 

contained in the Comprehensive Child Immunization Act of 1993 would increase direct spending and therefore is subject to the pay-as-you-go requirement of the Omnibus Budget Reconciliation Act of 1990.

The sources of revenue to pay for the direct spending increases contained in the bill will be identified in the President's legislation for broad-based reform of the national health care system when it is submitted to the Congress in May.

Accordingly, the pay-as-you-go cost is zero.